Eudralex Volume 3 CONCEPT PAPER ON THE DEVELOPMENT OF A QUALITY GUIDELINE ON
PHARMACEUTICAL DEVELOPMENT OF MEDICINES FOR PAEDIATRIC USE

This concept paper is intended as the first step to a scientific and harmonised approach to the development of a guideline that provides adequate tools for responsible development of a medicinal product for use in these different subsets of the paediatric population. Information sharing with authorities from other regions (e.g. the FDA) would further support global development.